Telix Pharmaceuticals Limited Q4 FY2025 earnings call

Strategic framing: Telix has a platform with 5 major segments including therapeutics pipeline, internal innovation model, Precision Medicine business, sales and commercial team, and manufacturing and supply chain. 2026 priorities: Continue to grow core business around approved products, launch 2 new products Pixclara and Zircaix, and focus on several high-value clinical programs with over 30 sponsored and collaborative studies running from early stage to pivotal trials.

Telix reported a 56% growth in revenue to $804 million in 2025, its third consecutive year of double-digit revenue growth. Revenue from the Precision Medicine business increased 22% year-over-year with EBITDA improving 25% to $216 million, driven by strong demand of Illuccix and the launch of Gozellix. The RLS acquisition delivered positive EBITDA for the first 11 months post-acquisition, and the remaining TMS facility increased investment to advance operational activities facilitating clinical and commercial supply.

2026 full year revenue guidance is set at $950 million to $970 million, anticipating roughly 20-plus percent revenue growth, with a full year of RLS revenue and a 25% growth in the Precision Medicine business. R&D investment is planned to be in the range of $200 million to $240 million in 2026, dependent on clinical outcomes and development milestones.

Regulatory risks related to FDA internal turmoil affecting product approvals; market competition risks from emerging competitors; supply chain risks due to short shelf life of radiopharmaceuticals impacting market share; and clinical study progress risks if trials don't meet expectations.

Q: At the risk of potentially making myself a bit unpopular, I think we'd like to understand a bit more about when we might see some data for 591, the safety data. And perhaps given that you said you will disclose at the same time that you go to the FDA, whether the next steps are things that you need to do at Telix or whether you're waiting for the FDA to do something on their end to be able to get to that point?

A: Laura, thanks for your question. It's not a bad question or an unpopular question at all. So we have had an independent data safety review board that has under the clinical charter of the study has reviewed the data and progressed to randomization ex-U.S. However, in order for us to send the information to the FDA and disclose the information publicly, we need just to complete the clinical case report forms and formally close out and quality control and validate the data because that's obviously what the FDA wants to see. As soon as we have that data -- and I haven't seen it, I'm not privy to it. But as soon as it's available, we will simultaneously disclose it and submit it to the FDA. So we're not waiting on anything from the FDA. It's all on the company side, and you will not have long to wait.

Q: This is Nick on for Tara. Congrats on the progress and the strong guidance for 2026. We were hoping that you can dive in a little more on what you've seen in the early innings of the 2-product strategy for Illuccix and Gozellix and how you anticipate that will evolve this year to reach the 25% growth in the precision medicine revenue?

A: Yes. Thanks very much for the question. Kevin, do you want to pick this one up for your wheelhouse?

Q: Sure. Yes. Thank you for the question. So the 2-product strategy is -- enables us to really manage the economic needs of HOPPS accounts and the way that they perceive and their preference for a reimbursed product over really a non-reimbursed product. As you know, MUC or Main Unit Cost has really kind of changed the environment and the reimbursement environment there as well as the way that the pricing happens in the HOPPS accounts. So being able to have a 2-product company enables us to manage that particular customer type and the self-standing -- or we call them IDTF group -- in a different way as we manage the preference they have for a reimbursement price or one that might be a little more price sensitive. So and then, of course, we have a longer view of the precision medicine business and PSMA specifically, as we think through what over time can happen and what will happen with CMS as they continue to evolve and change reimbursement. So that enables us to kind of manage the ASP, if you will, as the CMS may or look more towards the ASP reimbursement model. So it gives us options in the future without locking down a singular product on that.